Trial Outcomes & Findings for A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis (NCT NCT00317356)
NCT ID: NCT00317356
Last Updated: 2021-04-30
Results Overview
Definition of clinical improvement: Disease Activity Index (DAI) subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Weeks 4 and 8
Results posted on
2021-04-30
Participant Flow
Participant milestones
| Measure |
OPC-6535 12.5 mg
12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 25 mg
25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 50 mg
25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
|
Placebo
0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
9
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
3
|
Reasons for withdrawal
| Measure |
OPC-6535 12.5 mg
12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 25 mg
25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 50 mg
25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
|
Placebo
0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
0
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
OPC-6535 12.5 mg
n=11 Participants
12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 25 mg
n=11 Participants
25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 50 mg
n=10 Participants
25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
|
Placebo
n=11 Participants
0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Weeks 4 and 8Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
Definition of clinical improvement: Disease Activity Index (DAI) subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline
Outcome measures
| Measure |
OPC-6535 12.5 mg
n=11 Participants
12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 25 mg
n=11 Participants
25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 50 mg
n=10 Participants
25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
|
Placebo
n=11 Participants
0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
|---|---|---|---|---|
|
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration
|
27.3 percentage of participants
Interval 6.0 to 61.0
|
30.0 percentage of participants
Interval 6.7 to 65.2
|
50.0 percentage of participants
Interval 18.7 to 81.3
|
9.1 percentage of participants
Interval 0.2 to 41.3
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
Definition of remission: DAI subscores for both rectal bleeding and mucosal appearance improved to 0
Outcome measures
| Measure |
OPC-6535 12.5 mg
n=11 Participants
12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 25 mg
n=11 Participants
25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 50 mg
n=10 Participants
25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
|
Placebo
n=11 Participants
0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
|---|---|---|---|---|
|
Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration
Week 4
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
9.1 percentage of participants
Interval 0.2 to 41.3
|
|
Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration
Week 8
|
0.0 percentage of participants
Interval 0.0 to 28.5
|
9.1 percentage of participants
Interval 0.2 to 41.3
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
9.1 percentage of participants
Interval 0.2 to 41.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4 and 8Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician's rating of disease activity. Each item of the score is assessed on a 4-point scale from 0 to 3; the total score ranges from 0 to 12 with a higher score representing greater severity. A negative change in mean score indicates improvement.
Outcome measures
| Measure |
OPC-6535 12.5 mg
n=11 Participants
12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 25 mg
n=11 Participants
25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 50 mg
n=10 Participants
25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
|
Placebo
n=11 Participants
0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
|---|---|---|---|---|
|
Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration
Week 8
|
-2.6 score on a scale
Standard Deviation 2.2
|
-1.9 score on a scale
Standard Deviation 3.4
|
-3.8 score on a scale
Standard Deviation 2.2
|
-1.4 score on a scale
Standard Deviation 2.3
|
|
Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration
Week 4
|
-2.5 score on a scale
Standard Deviation 2.4
|
-1.0 score on a scale
Standard Deviation 3.0
|
-5.0 score on a scale
|
-2.3 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4 and 8Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician's rating of disease activity. Each item of the score is assessed on a 4-point scale from 0 to 3 with a higher score representing greater severity. A negative change in mean score indicates improvement.
Outcome measures
| Measure |
OPC-6535 12.5 mg
n=11 Participants
12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 25 mg
n=11 Participants
25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 50 mg
n=10 Participants
25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
|
Placebo
n=11 Participants
0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
|---|---|---|---|---|
|
Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration
Mucosal appearance at Week 8
|
-0.7 score on a scale
Standard Deviation 0.7
|
-0.5 score on a scale
Standard Deviation 0.7
|
-0.8 score on a scale
Standard Deviation 0.7
|
-0.3 score on a scale
Standard Deviation 0.7
|
|
Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration
Physician's rating of disease activity at Week 8
|
-0.5 score on a scale
Standard Deviation 0.5
|
-0.5 score on a scale
Standard Deviation 0.9
|
-1.0 score on a scale
Standard Deviation 0.7
|
-0.2 score on a scale
Standard Deviation 0.8
|
|
Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration
Rectal bleeding at Week 4
|
-0.6 score on a scale
Standard Deviation 0.8
|
-1.0 score on a scale
Standard Deviation 1.1
|
-0.9 score on a scale
Standard Deviation 0.7
|
-0.4 score on a scale
Standard Deviation 0.7
|
|
Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration
Rectal bleeding at Week 8
|
-0.7 score on a scale
Standard Deviation 0.9
|
-0.9 score on a scale
Standard Deviation 1.1
|
-1.1 score on a scale
Standard Deviation 0.9
|
-0.5 score on a scale
Standard Deviation 0.7
|
|
Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration
Mucosal appearance at Week 4
|
-0.5 score on a scale
Standard Deviation 0.6
|
-0.3 score on a scale
Standard Deviation 0.6
|
-1.0 score on a scale
|
-0.7 score on a scale
Standard Deviation 1.2
|
|
Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration
Stool frequency at Week 4
|
-0.4 score on a scale
Standard Deviation 1.0
|
-0.8 score on a scale
Standard Deviation 1.2
|
-0.8 score on a scale
Standard Deviation 0.8
|
-0.4 score on a scale
Standard Deviation 0.7
|
|
Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration
Stool frequency at Week 8
|
-0.5 score on a scale
Standard Deviation 1.1
|
-0.3 score on a scale
Standard Deviation 1.3
|
-0.6 score on a scale
Standard Deviation 0.7
|
-0.4 score on a scale
Standard Deviation 0.8
|
|
Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration
Physician's rating of disease activity at Week 4
|
-0.5 score on a scale
Standard Deviation 0.7
|
-0.7 score on a scale
Standard Deviation 1.0
|
-0.9 score on a scale
Standard Deviation 0.7
|
-0.4 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4 and 8Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
CAI composed of 7 variables: number of stool weekly, blood in stools (weekly average), investigator's global assessment of symptomatic state, abdominal pain/cramps, temperature due to colitis, extraintestinal manifestations, and laboratory findings. The scores ranging from 0 to 29 points (higher scores meaning more severe disease).
Outcome measures
| Measure |
OPC-6535 12.5 mg
n=11 Participants
12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 25 mg
n=11 Participants
25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 50 mg
n=10 Participants
25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
|
Placebo
n=11 Participants
0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
|---|---|---|---|---|
|
Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration
Week 2
|
-1.2 score on a scale
Standard Deviation 3.1
|
-2.4 score on a scale
Standard Deviation 3.7
|
-1.8 score on a scale
Standard Deviation 1.5
|
-1.0 score on a scale
Standard Deviation 1.8
|
|
Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration
Week 4
|
-1.4 score on a scale
Standard Deviation 2.3
|
-2.6 score on a scale
Standard Deviation 4.1
|
-2.9 score on a scale
Standard Deviation 2.3
|
-1.1 score on a scale
Standard Deviation 2.3
|
|
Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration
Week 8
|
-1.9 score on a scale
Standard Deviation 2.2
|
-2.6 score on a scale
Standard Deviation 3.9
|
-3.4 score on a scale
Standard Deviation 2.5
|
-1.0 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of subjects with inflammatory bowel disease. The IBDQ score was calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions that address symptoms as a result of Crohn's disease: bowel symptoms, systemic symptoms, emotional function, and social function. Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL.
Outcome measures
| Measure |
OPC-6535 12.5 mg
n=11 Participants
12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 25 mg
n=11 Participants
25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 50 mg
n=10 Participants
25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
|
Placebo
n=11 Participants
0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
|---|---|---|---|---|
|
Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration
|
22.5 score on a scale
Standard Deviation 26.5
|
7.1 score on a scale
Standard Deviation 44.3
|
16.0 score on a scale
Standard Deviation 40.2
|
9.3 score on a scale
Standard Deviation 32.9
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of subjects with inflammatory bowel disease. The IBDQ includes 32 items, which are divided into four subscales: bowel symptoms, systemic symptoms, emotional function and social function, and each item is scored on a 7-point scale, ranging from 1 (worst) to 7 (best). Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL.
Outcome measures
| Measure |
OPC-6535 12.5 mg
n=11 Participants
12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 25 mg
n=11 Participants
25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 50 mg
n=10 Participants
25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
|
Placebo
n=11 Participants
0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
|---|---|---|---|---|
|
Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration
Social function at Week 8
|
3.2 score on a scale
Standard Deviation 6.1
|
2.5 score on a scale
Standard Deviation 8.7
|
2.2 score on a scale
Standard Deviation 7.2
|
0.7 score on a scale
Standard Deviation 8.8
|
|
Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration
Bowel symptoms at Week 8
|
9.3 score on a scale
Standard Deviation 12.2
|
4.5 score on a scale
Standard Deviation 18.6
|
5.8 score on a scale
Standard Deviation 13.4
|
4.5 score on a scale
Standard Deviation 11.0
|
|
Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration
Systemic symptoms at Week 8
|
4.5 score on a scale
Standard Deviation 5.6
|
-1.1 score on a scale
Standard Deviation 8.5
|
2.2 score on a scale
Standard Deviation 7.0
|
0.0 score on a scale
Standard Deviation 5.9
|
|
Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration
Emotional function at Week 8
|
5.5 score on a scale
Standard Deviation 8.6
|
1.2 score on a scale
Standard Deviation 12.9
|
5.8 score on a scale
Standard Deviation 15.0
|
4.0 score on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Week 4Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
Definition of clinical improvement: DAI subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline
Outcome measures
| Measure |
OPC-6535 12.5 mg
n=11 Participants
12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 25 mg
n=11 Participants
25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 50 mg
n=10 Participants
25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
|
Placebo
n=11 Participants
0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
|---|---|---|---|---|
|
Clinical Improvement Rate After 4 Weeks of Study Drug Administration
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
Adverse Events
OPC-6535 12.5 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
OPC-6535 25 mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
OPC-6535 50 mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OPC-6535 12.5 mg
n=11 participants at risk
12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 25 mg
n=11 participants at risk
25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 50 mg
n=10 participants at risk
25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
|
Placebo
n=11 participants at risk
0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
18.2%
2/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
20.0%
2/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
Other adverse events
| Measure |
OPC-6535 12.5 mg
n=11 participants at risk
12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 25 mg
n=11 participants at risk
25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
OPC-6535 50 mg
n=10 participants at risk
25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks.
|
Placebo
n=11 participants at risk
0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Ear and labyrinth disorders
Ear discomfort
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Eye disorders
Eye pruritus
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
18.2%
2/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
18.2%
2/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
36.4%
4/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
20.0%
2/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Gastrointestinal disorders
Proctalgia
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
18.2%
2/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
10.0%
1/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
General disorders
Asthenia
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
General disorders
Feeling abnormal
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
General disorders
Malaise
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
General disorders
Pyrexia
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Infections and infestations
Influenza
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
18.2%
2/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
10.0%
1/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
27.3%
3/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
10.0%
1/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
10.0%
1/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Investigations
Blood urine present
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
10.0%
1/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
10.0%
1/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Investigations
White blood cell count increased
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
27.3%
3/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
10.0%
1/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Investigations
Protein urine present
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
10.0%
1/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
10.0%
1/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
27.3%
3/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
30.0%
3/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
18.2%
2/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
9.1%
1/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
10.0%
1/10 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
0.00%
0/11 • Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Phone: +81-3-6361-7366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place